Utility of Extracted Colored Ion – Associate Complexes Formation Reaction for the Determination of Fexofenadine Hydrochloride in Pure Forms and in Dosage Forms

Alaa S Amin,Ibrahim S Ahmed,Hassan A Mohamed

doi:10.4172/2157-7048.1000101

Abstract

A spectrophotometric reliable, rapid and sensitive methods have been developed and validated for the determination of fexofenadine hydrochloride. A method was described for the determination of fexofenadine hydrochloride in pure form or pharmaceutical formulations using bromophenol blue (BPB) bromothymol blue (BTB), bromocresol green (BCG) and bromocresol purple (BCP). This method involved the formation of colored chloroform (CHCl3) extractable ion-associate complexes with BPB, BTB, BCG and BCP in acidic medium. All variables affecting the reaction have been investigated and the conditions were optimized. The extracted complexes showed absorbance maximum at λmax 411, 414, 409, and 411 nm, respectively. The reagents form a chloroform – soluble colored ion association complex with fexofenadine hydrochloride at pH 2.4, 2.4, 2.2 and 2.4 using BPB, BCG, BTB and BCP respectively. Regression analysis of Beer –Lambert plots showed good correlation in the concentration ranges 1.0 – 6.0, 0.5 – 9.0, 1.0 – 8.0 and 0.5 – 6.0 μg mL–1, respectively. The apparent molar absorptivity. Sandell sensitivity, detection and Quantitation limits were calculated. Applications of the proposed methods to representative pharmaceutical formulations are successfully presented.

Highlights

Fexofenadine hydrochloride [1,2], -Dimethyl-4-[4(hydroxydiphenyl methyl-1-piperidinyl] benzene acetic acid (Figure 1), is the active compound of the pharmaceutical formulations, and active metabolite of terfenadine, is a non –sedating antihistamine H1-receptor antagonist
Effect of pH: To examined the optimum pH value for each ion - associates formed between fexofenadine hydrochloride and bromophenol blue (BPB), bromocresol green (BCG), bromothymol blue (BTB) and bromocresol purple (BCP) different types of buffer [31] were used
The ion associate formed in acidic medium and the best buffer was universal and acetate buffer solution

Summary

Introduction

Fexofenadine hydrochloride [1,2], , -Dimethyl-4-[4(hydroxydiphenyl methyl-1-piperidinyl] benzene acetic acid (Figure 1), is the active compound of the pharmaceutical formulations, and active metabolite of terfenadine, is a non –sedating antihistamine H1-receptor antagonist. It does not possess significant sedative or antimuscarinic actions. Fexofenadine hydrochloride has been determined employing anodic voltammetry as well as HPLC with different detections, including ultraviolet [13], mass spectrometry [14,15,16] fluorescence [17] and spectrophotometric method [18,19,20]

Methods

Results

Conclusion